OMNILife Apex K2 Modular Femoral Stem
The Apex K2 modular femoral stem, which is used in hip replacement surgery, is associated with higher than expected failure rates. OMNILife Sciences, based in Massachusetts, manufactures the implant.
In October 2012, the Australian regulatory authorities announced that the Apex K2 modular femoral stem was withdrawn from the market in Australia because it had "higher than expected revision rates."
Although the Apex femoral stem is sold in the United States, the Australian authorities have been at the forefront of investigating the failures of these implants. The most recent report from the National Joint Registry in Australia shows that the Apex modular femoral stem has a 7.6% revision rate at 10 years. In 2016, the Australian Registry conducted a detailed investigation of the Apex stem. They found 106 revisions from 2,204 reported and the cumulative percent revision at 10 years was 8.6%. There were 81 major revisions and the Apex stem was combined with 30 different acetabular components. There were 24 revisions for loosening/lysis, 25 for dislocation and 17 for infection. There were
revisions in all five states and territories that used the device.